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A Phase I/II, Multi-center, Open-label Study of BGT226, Administered Orally in Adult Patients With Advanced Solid Malignancies Including Patients With Advanced Breast Cancer


Phase 1/Phase 2
18 Years
N/A
Not Enrolling
Both
Solid Tumors, Breast Cancer, Cowden Syndrome

Thank you

Trial Information

A Phase I/II, Multi-center, Open-label Study of BGT226, Administered Orally in Adult Patients With Advanced Solid Malignancies Including Patients With Advanced Breast Cancer

Inclusion Criteria


Inclusion criteria:

All patients

- Histologically-confirmed, advanced solid tumors

- Progressive, recurrent unresectable disease

Phase II expansion part (advanced breast cancer)

- Confirmed positive hormone receptor (estrogen receptor and/or progesterone receptor)
or positive HER-2 expression status

- Disease progression/recurrence following hormonal or anti-HER-2 treatment for
advanced disease

- At least one but not more than two prior chemotherapy regimens for the unresectable
tumor

- Measurable disease by MRI or CT scan

Cowden Syndrome patients with an advanced malignancy Genetic confirmation of Cowden
Syndrome

- Age ≥ 18

- World Health Organization (WHO) Performance Status of ≤ 2

Exclusion criteria:

- Hematopoietic:

- No diabetes mellitus or history of gestational diabetes mellitus

- No acute or chronic renal disease

- No acute or chronic liver disease

- No acute or chronic pancreatitis

- No impaired cardiac function or clinically significant cardiac diseases such as
ventricular arrhythmia, congestive heart failure, uncontrolled hypertension

- No acute myocardial infarction or unstable angina pectoris within the past 3 months

- Not pregnant or nursing and fertile patients must use barrier contraceptives

Other protocol-defined inclusion/exclusion criteria may apply.

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Maximum Tolerated Dose (MTD) of BGT226 (Phase I dose escalation) Safety and tolerability of BGT226 (all patients) Clinical tumor response in patients with advanced breast cancer (Phase II)

Outcome Time Frame:

throughout the study

Safety Issue:

Yes

Principal Investigator

Novartis Pharmaceuticals

Investigator Role:

Study Director

Investigator Affiliation:

Novartis Pharmaceuticals

Authority:

United States: Food and Drug Administration

Study ID:

CBGT226A2101

NCT ID:

NCT00600275

Start Date:

December 2007

Completion Date:

Related Keywords:

  • Solid Tumors
  • Breast Cancer
  • Cowden Syndrome
  • BGT226
  • Solid tumors
  • Breast cancer
  • Cowden Syndrome
  • Phosphatidylinositol 3'-kinase (PI3K) inhibitor
  • Advanced solid tumors (including sporadic and Cowden Syndrome) (Phase I part)
  • Advanced breast cancer (including sporadic and Cowden Syndrome) (Phase II part)
  • Breast Neoplasms
  • Hamartoma Syndrome, Multiple

Name

Location
Nevada Cancer Center Las Vegas, Nevada  89109
Massachusetts General Hospital Boston, Massachusetts  02114-2617
Dana Faber Cancer Institute Boston, Massachusetts  02115
Cancer Therapy and Research Center (CTRC) San Antonio, Texas  78229